Clinical Research Coordinator II

Temporary Position

Qualifications:

BA Degree in Life Science-based degree

GCP, HIPAA, Conflict of Interest training (CITI coursework available, if needed)

• Attend and productively participate in staff meetings and trainings as needed
• Maintain high degree of responsibility for client confidentiality
• Maintain a pleasant, courteous, tactful attitude with all contacts
• Work with minimal supervision in exercising initiative in organizing and completing daily tasks
• Solve minor problems by using judgment based on knowledge of Institute policies and department practices and procedures
• Meet established productivity and task management standards for assigned duties
• Overtime is a condition of employment and may be required based on the needs of the Institute
• Responsible for other tasks as may be required for efficient operation of the department

Responsibilities:

• Interpret, adhere to, and enforce detailed research protocols and regulatory requirements from Screening to Study Close-out. Maintain the Investigator Binder and Subject Binder in a complete and orderly manner, available for audits at any time.
• Schedule subjects for study procedures; initiate/coordinate drug orders, laboratory procedures and treatments for patients based on standing protocol orders. Coordinate appointments for subjects with their assigned specific facilitator. Complete CRFs and forms for subject-related costs reimbursement.
• Adhere to documentation procedures to ensure cGMP and GCP. Implement GCP and HIPAA compliance for all study-related activities.
• Communicate effectively with team members, research manager, and physicians via oral, written, and teleconferencing for study-related and ancillary activities. Present research findings to the supervisor through verbal and written communications.
• Maintain confidentiality of patient-relate records (HIPAA) including written and verbal communications.